Kornimate/medical-research-clean huggingface dataset:
efficacy of eflornithine hydrochloride cream in the treatment of melasma: a randomized, double-blinded, split-face controlled study

Conditions: Melasma

Summary: the goal of this clinical trial is to learn if eflornithine hydrochloride cream works to treat melasma in adults, in comparison to hydroquinone cream. it will also learn about the safety of eflornithine hydrochloride cream. the main questions it aims to answer are: * does eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to hydroquinone cream? * what side effects might patients get while using eflornithine hydrochloride cream? participants will: * apply both eflornithine hydrochloride and hydroquinone creams on separate halves of their faces every day for 3 months. * visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of melasma * fitzpatrick type iii or iv * able to provide informed consent exclusion criteria: * pregnant or lactating patients * patients with difficulty adhering to regular topical treatments * patients with known contact allergies to any of the ingredients in the topical medications used in the study

Keywords: melasma dermatology eflornithine
transcranial direct current stimulation and rehabilitation to ameliorate impairments in neurocognition after stroke

Conditions: Ischemic Stroke; Cognitive Impairment

Summary: the purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tdcs), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.

this is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tdcs) paired with cognitive therapy. subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at penn institute for rehabilitation medicine. neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. the investigators will examine changes in cognitive performance induced by tdcs + cognitive therapy compared to sham tdcs + cognitive therapy. this study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.

Eligibility criteria:
inclusion criteria: * stroke that occurred within 4 weeks of the study * presence of cognitive impairment attributable to stroke * between the ages of 18 and 90 * able to understand the nature of the study and give informed consent * able to follow simple commands as evidenced by nihss subtest 1c =0 exclusion criteria * history of chronic, serious, or unstable neurologic illness other than stroke * current unstable medical illness(es) * history of reoccurring seizures or epilepsy * current abuse of alcohol or drugs (prescription or otherwise) * active and severe psychiatric disorder * metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants. * pregnancy

Keywords: post-stroke cognitive impairment transcranial direct current stimulation neurorehabiliation
amino acid chelated iron versus ferrous fumarate in the treatment of iron deficiency anemia with pregnancy: randomized controlled trial

Conditions: Iron Deficiency Anemia

Summary: anemia is the commonest hematological disorder that occurs in pregnancy. according to the recent standard laid down by 'who', anemia is present when the hemoglobin (hb) concentration in the peripheral blood is 11 gm/dl or less. the most common cause of anemia in pregnancy is lack of iron. this study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

anemia is the commonest hematological disorder that occurs in pregnancy. according to the recent standard laid down by 'who', anemia is present when the hemoglobin (hb) concentration in the peripheral blood is 11 gm/dl or less. the most common cause of anemia in pregnancy is lack of iron. this study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Eligibility criteria:
inclusion criteria: * pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound * hemoglobin level 8-10.5 g/dl * serum ferritin\<15µg/l exclusion criteria: * the presence of anemia from causes other than iron deficiency(e.g: folat deficiency anemia,vitamin b12 deficiency, ect...). * multiple gestations * the presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease * patients with known gastritis * history of mal-absorption syndrome * those with known hypersensitivity to iron preparations * those under current iron supplementation
introductory clinical trial for measuring patients before, during, and after an electrophysiology (ep) procedure with a novel, body-worn sensor

Conditions: Atrial Fibrillation; Ventricular Tachycardia

Summary: subjects will be consented to wear the cova-2 monitoring system prior to (baseline), during, and after an electrophysiology procedure (ep). during this time, the system will measure the following parameters from subjects: heart rate (hr), heart rate variability (hrv), respiration rate (rr), and cardiac output (co). data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. subjects will not be measured while transferred in and out of the operating room. approximate sample size is 20 subjects.


Eligibility criteria:
inclusion criteria: 1. patients with arrhythmias and other cardiac conditions that are scheduled for ep procedures. 2. subject is over 22 years of age at the time of consenting 3. subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study exclusion criteria: 1. pregnant subjects 2. subjects who are participating in another clinical study that may affect the results of either study 3. subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours 4. subjects who are considered by the principle investigator to be medically unsuitable for study participation
wearable gait sensors

Conditions: Spinocerebellar Ataxia

Summary: this research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of spinocerebellar ataxia.

study participants will complete a neurological exam with sensors (isara exam) and three patient-reported questionnaires (prom-ataxia, abc scale, eq-5d-5l). participation will take about an hour.

Eligibility criteria:
inclusion criteria: * ataxia group - individuals who have a genetic-confirmation of sca diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions. * healthy control group - individuals who are able to sit or stand unassisted for 30 seconds and follow directions. exclusion criteria: * any other neurological or musculoskeletal disorder not attributed to the sca that could affect balance, gait or voluntary movement.
haic plus pd-1 antibody vs haic plus sorafenib for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (haic) combined with programmed cell death protein-1 (pd-1) antibody compared with haic plus sorafenib in patients with advanced hepatocellular carcinoma (hcc)

the results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (haic) may improve the survivals for advanced hepatocellular (hcc). programmed cell death protein-1 (pd-1) antibody has been proved effective and safety for advanced hcc. there is no study about haic plus pd-1 antibody. thus, the investigators carried out this prospective randomized control study to compare haic plus sorafenib and haic plus pd-1 antibody.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * major portal vein tumor thrombus (vp3,vp4) * eastern cooperative oncology group performance status of 0 to 1 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection, local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/μl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic arterial infusion chemotherapy programmed cell death protein-1 antibody oxaliplatin, 5-fluorouracil and leucovorin
gemcitabine in ovarian cancer

Conditions: Ovarian Cancer

Summary: the primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of gemcitabine at a dose 1250 mg/m2 (day 1 and 8) with cisplatin 75 mg/m2 (day 1) as first-line treatment


Eligibility criteria:
inclusion criteria: * ecog = 0-2 * operated patients * disease stage iii-iv exclusion criteria: * no prior chemotherapy or radiation therapy
sd vs. nsd therapy in elderly aml

Conditions: Standard Therapy; Non-standard Therapy

Summary: it is known that treatment outcome could be positively associated with treatment intensity. however, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (sd) therapy and even died of side effect, and overall survival (os) might not be prolonged. whether all elder acute myeloid leukemia (aml) patients could benefit from sd therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. in this multi-center study, we are going to evaluate the benefit of sd and non-sd (nsd) therapy in elder aml patients.

it is known that treatment outcome could be positively associated with treatment intensity. however, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (sd) therapy and even died of side effect, and overall survival (os) might not be prolonged. whether all elder acute myeloid leukemia (aml) patients could benefit from sd therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. sd therapy is definited as the treatment regimen must follow nccn guildline and chemotherapy intensity could not be reduced. non-sd (nsd) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. in this multi-center study, we are going to evaluate the benefit of sd and nsd therapy in elder aml patients.

Eligibility criteria:
inclusion criteria: newly diagnosed aml exclusive of apl; age from 60 years old to 75 years old. exclusion criteria: any abnormality in a vital sign (e.g., organ function failure, serious infection ) patients with any conditions not suitable for the trial (investigators' decision)
efficiency of favourite versus predetermined musical sequence on gynecology pre-operative anxiety

Conditions: Surgery; Anxiety State

Summary: anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. high levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. anxiety also increases pain and post-surgery morbi-mortality. drug-induced sedation is frequently recommended to lower anxiety. the anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening. in the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device music care. in this study, the anxiolytic effect of predefined u musical sequences that alternate slow and faster music tracks (medical device music care) are compared to patient's play-list, in women with planned gynecological surgery.

patients are randomly allocated in two groups: * control group: patients are asked to choose one of the u sequence among the preselected music style proposed by the medical device music care * test group: patients are asked to prepare their own play-list containing their favourite songs anxiety is assessed before and after a 20 min-musicotherapy session by using the state-trait anxiety inventory (stai) for anxiogenic situation. other parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.

Eligibility criteria:
inclusion criteria: * with planed gynecologic surgery * without anxiolytic medication * able to prepare their own play-list * signed inform consent exclusion criteria: * hearing disorder * dementia or psychiatric disorder * neurologic disorder
muscle characteristics associated with statin therapy

Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myopathy

Summary: the purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. the pathophysiology of these events remains obscure. previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. we will quantify these entities pre and post statin therapy to better understand these reactions.

Eligibility criteria:
inclusion criteria: * primary surgeon's permission. * patient is \> 21 years of age. * patient will go through a two phase surgery with the two procedures one to eight months apart. * patient or representative understands the nature of the study. * normal thyroid stimulating hormone (tsh). * ldl-cholesterol \> 100 mg/dl or highly sensitive c-reactive protein (hscrp) \> 2.0. * one of the following risk factors: male \> 45 year old or female \> 55 year old, smoker, hypertension, first degree family history of coronary artery disease \< 55 year old, hdl \<40 mg/dl, chronic kidney disease, diabetes mellitus, previous tia or stroke, previous coronary artery disease. exclusion criteria: * has been on a lipid-lowering medication previously. * severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy. * less than a 10% reduction of ldl after 3 months of therapy (indicative of non-adherence). * contraindications to statins such as liver failure. * history of underlying muscle disorder. * taking amiodarone.

Keywords: statin myopathy hydroxymethylglutaryl-coa reductase inhibitors atrogin-1
opioid effects on swallowing comparing younger and elderly volunteers

Conditions: Pharyngeal Dysfunction; Pharyngeal Swallowing

Summary: the purpose of the study is to determine whether remifentanil influence the pharyngeal phase of swallowing using using pressure and impedance recordings. the purpose is also to compare remifentanil to morphine and younger to elderly volunteers.

remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in postoperative patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. in a previous study (not yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers and the aim of this study is to objectively determine weather remifentanil infusion in healthy volunteers influence the pharyngeal phase of swallowing. the purpose is also compare the effect of remifentanil to morphine and younger volunteers to elderly volunteers. to assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30 minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg) at the other. the volunteers are asked to swallow 10 ml normal saline several times both before and after opioid administration and pharyngeal motility is parallelly recorded using combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal segment. any subjective swallowing difficulties are also recorded.

Eligibility criteria:
inclusion criteria: * 18-30 or 65 \< year old healthy volunteers from both sexes. * have signed and dated informed consent. * willing and able to comply with the protocol for the duration of the trial. exclusion criteria: * pharyngoesophageal dysfunction * known history of cardiac, pulmonary or neurological disease * ongoing medication * allergies to or history of reaction to remifentanil, fentanyl analogues or other ingredients * pregnancy or breast feeding * bmi \> 30 * previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not complete.

Keywords: remifentanil pharyngeal dysfunction subjective swallowing difficulties pulmonary aspiration
intervening on women's health for rural young cancer survivors

Conditions: Cancer; Fertility Issues; Contraception

Summary: the purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. the investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.


Eligibility criteria:
inclusion criteria: * cancer (stages 0-iv) diagnosis * primary language english or spanish * receiving oncology care at rural oncology clinical participating site * living in imperial county, california exclusion criteria: - women who are pregnant at recruitment

Keywords: reproductive health oncofertility
melphalan, prednisone and thalidomide versus melphalan and prednisone in elderly myeloma patients

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether the association of thalidomide to melphalan and prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.

intermittent courses of melphalan and prednisone (mp) have been the first line therapy in multiple myeloma, for many years. advances in systemic and supportive therapy increased remission rates and overall survival, but multiple myeloma still remains an incurable haematological malignancy. several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%. due to its activity, thalidomide will be evaluated in association with mp in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.

Eligibility criteria:
inclusion criteria: * untreated myeloma patients * age \>65 years of age or younger but excluded from transplant procedure * durie \& salmon stage ii or iii myeloma and measurable disease. * patients agreed to use contraception exclusion criteria: * other cancer * psychiatric disease and any grade 2 peripheral neuropathy

Keywords: myeloma thalidomide diagnosis elderly patients
visual performance of four types of multifocal intraocular lenses

Conditions: Cataract

Summary: this investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal iols: at lisa tri, panoptix, restor, and symfony. the clinical results demonstrated here were excellent for four groups, however, there were also differences in group restor, ucva and bcva for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.multifocal iols demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the panoptix and at lisa tri lens provided better vision in all distances. spectacle independence was significantly higher with four groups. multifocal iol design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. although there were differences in the results of these four lenses in the study, all of the results were acceptable.


Eligibility criteria:
inclusion criteria: * preoperative bcva (distance) more impacted than 20/40 * glare va test comes about worse than 20/40, or practically impairing dissensions about their vision. * by reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery. * express a want for multifocal vision, and be ready and ready to conform to the investigation necessities exclusion criteria: * excluded from entry were subjects with regular astigmatism greater than 1.5 d or irregular astigmatism. * large pupil * corneal transplant surgery or previous glaucoma-filtering, * a history of retinal detachments. * also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis, * endothelial disease * iris neovascularization, and amblyopia)